The Quality assurance manual for the pharmaceutical and medical device industries



Compact Regs good laboratory practices (GLP)

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004214587 / 1996-02-09
Date of Publication:
October 1, 1995
Date of Creation:
1995
Title:
Compact Regs good laboratory practices (GLP) : code of federal regulations.
Description:
39 p.
Variant title:
Compact Regs good laboratory practices (GLP) : code of federal regulations
Copyright Claimant:
on editing; Interpharm Press, Inc.
Names:
Interpharm Press, Inc. (125 documents)
example document: Continuous improvement in the healthcare manufacturing industry

Copyrights records by Interpharm Press, Inc.

Compact Regs

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004217522 / 1996-02-27
Date of Publication:
October 1, 1995
Date of Creation:
1995
Title:
Compact Regs : good clinical practices (GCP) : code of federal regulations.
Description:
118 p.
Number of similar titles:
2
Variant title:
Compact Regs : good clinical practices (GCP)
Copyright Claimant:
Interpharm Press, Inc.
Names:
Interpharm Press, Inc. (125 documents)
example document: Building blocks

Interpharm guide

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004218570 / 1996-02-27
Date of Publication:
December 1, 1995
Date of Creation:
1995
Title:
Interpharm guide : FDA international inspections : vol. 1, 1990-1993 / Michael Anisfeld, 1946-.
Description:
1 v.
Number of similar titles:
2
Variant title:
Interpharm guide : FDA international inspections : vol. 1, 1990-1993
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Anisfeld 1946-
Interpharm Press, Inc. (125 documents)
example document: Guide to formulation for safety testing

Compact Regs medical device and equipment GMPS

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004222093 / 1996-02-26
Date of Publication:
October 1, 1995
Date of Creation:
1995
Title:
Compact Regs medical device and equipment GMPS : code of federal regulations.
Description:
30 p.
Variant title:
Compact Regs medical device and equipment GMPS : code of federal regulations
Copyright Claimant:
Interpharm Press, Inc.
Names:
Interpharm Press, Inc. (125 documents)
example document: Lyophilization

How to organize a validation file

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004235931 / 1996-03-11
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to organize a validation file : facilitator's manual / Michael Cutter.
Series:
GMP training series
Imprint:
Buffalo Grove, IL : Interpharm Press, c1995.
Description:
2 v. in 1 + sheets.
Number of similar titles:
5
Other Title:
GMP training series
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: Write it down

How to perform retrospective validation

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004235932 / 1996-03-12
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to perform retrospective validation : facilitator's manual / Michael Cutter.
Series:
GMP training series
Imprint:
Buffalo Grove, IL : Interpharm Press, c1995.
Description:
2 v. in 1 + sheets.
Number of similar titles:
4
Other Title:
GMP training series
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: Lyophilization

Managing the analytical laboratory

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004240470 / 1996-07-08
Date of Publication:
May 6, 1996
Date of Creation:
1996
Title:
Managing the analytical laboratory : plain and simple / Clifford L. Nilsen.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1996.
Description:
337 p.
Number of similar titles:
2
Variant title:
Managing the analytical laboratory : plain and simple
Copyright Claimant:
Interpharm Press, Inc.
Names:
Clifford L. Nilsen
Interpharm Press, Inc. (125 documents)
example document: Continuous improvement in the healthcare manufacturing industry

How to perform retrospective validation

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004242717 / 1996-02-27
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to perform retrospective validation / Michael Cutter.
Series:
GMP training series
Imprint:
Buffalo Grove, IL : Interpharm Press, c1995.
Description:
34 p.
Number of similar titles:
4
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: Quality assurance SOPs for GLP compliance

How to prepare for an FDA inspection

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004243293 / 1996-03-11
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to prepare for an FDA inspection : facilitator's manual / Michael Cutter, 1960-.
Series:
GMP training series
Description:
Kit.
Number of similar titles:
5
Other Title:
GMP training series
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: International pharmaceutical registration.

How to review and redesign SOP systems

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004259489 / 1996-04-05
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to review and redesign SOP systems : facilitator's manual / Michael Cutter, 1960-.
Series:
GMP training series
Description:
1 v.
Number of similar titles:
5
Other Title:
GMP training series
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: Building blocks

How to organize a validation file

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004259998 / 1996-02-26
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to organize a validation file / Michael Cutter.
Series:
GMP training series
Imprint:
Buffalo Grove, IL : Interpharm Press, c1995.
Description:
34 p.
Number of similar titles:
5
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: Building blocks

How to review and redesign SOP systems

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004259999 / 1996-02-26
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to review and redesign SOP systems / Michael Cutter.
Series:
GMP training series
Imprint:
Buffalo Grove, IL : Interpharm Press, c1995.
Description:
37 p.
Number of similar titles:
5
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: Process engineering applications

How to write policies and procedures

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004260464 / 1996-02-26
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to write policies and procedures / Michael Cutter.
Series:
CMP training series
Description:
35 p.
Number of similar titles:
6
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: International pharmaceutical registration.

International stability testing

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004262628 / 1998-10-05
Date of Publication:
September 14, 1998
Date of Creation:
1998
Title:
International stability testing / edited by David J. Mazzo.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1999.
Description:
332 p.
Number of similar titles:
1
Copyright Claimant:
Interpharm Press, Inc.
Names:
David J. Mazzo 1956-
Interpharm Press, Inc. (125 documents)
example document: Software quality assurance

How to apply quality assurance principles

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004264613 / 1996-02-27
Date of Publication:
August 1, 1995
Date of Creation:
1995
Title:
How to apply quality assurance principles / Michael Cutter.
Description:
30 p.
Number of similar titles:
5
Copyright Claimant:
Interpharm Press, Inc.
Names:
Michael Cutter 1960-
Interpharm Press, Inc. (125 documents)
example document: EPA-speak

Safety in electromedical technology

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004326478 / 1996-07-03
Date of Publication:
May 10, 1996
Date of Creation:
1996
Title:
Safety in electromedical technology / Norbert Leitgeb.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1996.
Description:
184 p.
Number of similar titles:
2
Copyright Claimant:
Interpharm Press, Inc.
Names:
Norbert Leitgeb 1949-
Interpharm Press, Inc. (125 documents)
example document: Software development and quality assurance for the healthcare manufacturing industries

The GCP harmonization handbook

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004327394 / 1996-07-08
Date of Publication:
April 30, 1996
Date of Creation:
1996
Title:
The GCP harmonization handbook / Donald E. Maynard, Robert S. DeWoskin.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1996.
Description:
469 p.
Number of similar titles:
2
Copyright Claimant:
Interpharm Press, Inc.
Names:
Robert S. DeWoskin (5 documents)
example document: Quality assurance SOPs for GLP compliance

Copyrights records by DeWoskin, Robert S.

Donald E. Maynard 1933-
Interpharm Press, Inc. (125 documents)
example document: Control of particulate matter contamination in healthcare manufacturing

Respiratory drug delivery V

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004367481 / 1996-09-26
Date of Publication:
April 1, 1996
Date of Creation:
1996
Title:
Respiratory drug delivery V : program and proceedings / editors, Richard N. Dalby, Peter R. Byron, Stephen J. Farr.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1996.
Description:
434 p.
Number of similar titles:
1
Similar Title:
Respiratory drug delivery V
Copyright Claimant:
Interpharm Press, Inc.
Names:
Peter R. Byron
Stephen J. Farr
Richard N. Dalby 1962-
Interpharm Press, Inc. (125 documents)
example document: Good computer validation practices

Sterile product facility design and project management

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004371994 / 1996-09-26
Date of Publication:
September 1, 1996
Date of Creation:
1996
Title:
Sterile product facility design and project management / Jeffery N. Odum, 1956-.
Description:
450 p.
Number of similar titles:
1
Copyright Claimant:
Interpharm Press, Inc.
Names:
Jeffery N. Odum 1956-
Interpharm Press, Inc. (125 documents)
example document: Automated microbial indentification and quantitation

Hazard study and risk assessment in the pharmaceutical industry

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004472413 / 1997-02-03
Date of Publication:
September 1, 1996
Date of Creation:
1996
Title:
Hazard study and risk assessment in the pharmaceutical industry / John Edward Gillett.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
369 p.
Number of similar titles:
2
Copyright Claimant:
Interpharm Press, Inc.
Names:
John Edward Gillett 1937-
Interpharm Press, Inc. (125 documents)
example document: Validation fundamentals

Good pharmaceutical freeze-drying practice

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004478700 / 1997-02-04
Date of Publication:
January 29, 1997
Date of Creation:
1997
Title:
Good pharmaceutical freeze-drying practice / editor, Peter Cameron ; contributors, L. David Butler, Peter Cameron, Kevin Kinnarney ... [et al.].
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
303 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
L. David Butler
Kevin Kinnarney
Peter Cameron 1954-
Interpharm Press, Inc. (125 documents)
example document: No titles given

Validation of bulk pharmaceutical chemicals

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004539209 / 1997-04-24
Date of Publication:
April 1, 1997
Date of Creation:
1997
Title:
Validation of bulk pharmaceutical chemicals / Daniel Harpaz, Ira R. Berry.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
496 p.
Number of similar titles:
2
Copyright Claimant:
Interpharm Press, Inc.
Names:
Ira R. Berry 1942-
Daniel Harpaz 1944-
Interpharm Press, Inc. (125 documents)
example document: Guide to formulation for safety testing

FDA inspections

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004547211 / 1997-04-04
Date of Publication:
March 26, 1997
Date of Creation:
1997
Title:
FDA inspections : a guide for medical device and diagnostic manufacturers / John S. Adcock.
Copyright Note:
C.O. correspondence.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
185 p.
Number of similar titles:
2
Variant title:
FDA inspections : a guide for medical device and diagnostic manufacturers
Copyright Claimant:
Interpharm Press, Inc.
Names:
John S. Adcock 1945-
Interpharm Press, Inc. (125 documents)
example document: GLP essentials

Physician investigator handbook

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004558611 / 1997-05-09
Date of Publication:
April 23, 1997
Date of Creation:
1997
Title:
Physician investigator handbook : GCP tools and techniques / Deborah Rosenbaum, Fred Smith.
Series:
Practical clinical trials series
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
418 p.
Number of similar titles:
5
Variant title:
Physician investigator handbook : GCP tools and techniques
Other Title:
Practical clinical trials series
Copyright Claimant:
Interpharm Press, Inc.
Names:
Fred O. Smith 1935-
Deborah L. Rosenbaum 1956-
Interpharm Press, Inc. (125 documents)
example document: Lyophilization

Transdermal and topical drug delivery systems

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004566454 / 1997-06-18
Date of Publication:
June 13, 1997
Date of Creation:
1997
Title:
Transdermal and topical drug delivery systems / Tapash K. Ghosh, William R. Pfister, editors-in-chief, Su Il Yum, associate editor.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
713 p.
Copyright Claimant:
Interpharm Press, Inc.
Names:
Tapash K. Ghosh 1958-
William R. Pfister 1951-
Su Il Yum 1939-
Interpharm Press, Inc. (125 documents)
example document: Biotechnology & biopharmaceutical manufacturing, processing & preservation

Validating automated manufacturing and laboratory applications

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004579097 / 1997-06-27
Date of Publication:
June 24, 1997
Date of Creation:
1997
Title:
Validating automated manufacturing and laboratory applications : putting principles into practice / Guy Wingate.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1997.
Description:
564 p.
Number of similar titles:
2
Copyright Claimant:
Interpharm Press, Inc.
Names:
Guy Wingate 1965-
Interpharm Press, Inc. (125 documents)
example document: Software development and quality assurance for the healthcare manufacturing industries

Good drug regulatory practices

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004658574 / 1997-10-22
Date of Publication:
September 24, 1997
Date of Creation:
1997
Title:
Good drug regulatory practices : a regulatory affairs quality manual / Helene I. Dumitriu.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1998.
Description:
426 p.
Number of similar titles:
2
Copyright Claimant:
Interpharm Press, Inc.
Names:
Helene I. Dumitriu 1961-
Interpharm Press, Inc. (125 documents)
example document: Sterilization of drugs and devices

International medical device clinical investigations

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004685404 / 1997-12-08
Date of Publication:
December 4, 1997
Date of Creation:
1997
Title:
International medical device clinical investigations : a practical approach / edited by Herman Pieterse, M. G. DeJong, Peter Duijst.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1998 [1997]
Description:
530 p.
Number of similar titles:
5
Variant title:
International medical device clinical investigations : a practical approach
Copyright Claimant:
Interpharm Press, Inc.
Names:
Herman Pieterse 1953-
Peter Duijst 1951-
M. G. deJong 1955-
Interpharm Press, Inc. (125 documents)
example document: No titles given

Microbial limit and bioburden tests

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004712262 / 1998-02-04
Date of Publication:
January 23, 1998
Date of Creation:
1998
Title:
Microbial limit and bioburden tests : validation approaches and global requirements / Lucia Clontz.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1998.
Description:
230 p.
Number of similar titles:
2
Copyright Claimant:
Interpharm Press, Inc.
Names:
Lucia Clontz 1957-
Interpharm Press, Inc. (125 documents)
example document: Pre-production quality assurance for healthcare manufacturers

Pharmaceutical applications in the European Union

Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004724184 / 1998-02-18
Date of Publication:
February 12, 1998
Date of Creation:
1998
Title:
Pharmaceutical applications in the European Union : a guide through the registration maze / Cheng Yee Lowe.
Imprint:
Buffalo Grove, IL : Interpharm Press, c1998.
Description:
263 p.
Number of similar titles:
2
Copyright Claimant:
Interpharm Press, Inc.
Names:
Cheng Yee Lowe 1939-
Interpharm Press, Inc. (125 documents)
example document: Write it down
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